RecruitingNot ApplicableNCT05775198

Effect of Intrauterine Administration of Autologous PBMC Modulated With IFNt on IVF Outcome

Effects of Intrauterine Administration of Autologous Peripheral Blood Mononuclear Cells (PBMC) Immunomodulated With Interferon Tau (IFNt) Prior to Embryo Transfer on IVF Outcome

Sponsor

Nadezhda Women's Health Hospital

Enrollment

300 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

Infertility, Female IVF

Summary

The goal of this clinical trial is to test the effect of modulated specialised immune cells isolated from the patients' own blood when administered to the uterus before embryo transfer on the IVF outcome (implantation, pregnancy and live birth rates). To achieve this, blood will be obtained from eligible participants. Target cells will be isolated and incubated with the tested modulator for 24h, and returned to the uterine cavity 1 day prior to embryo transfer. Researchers will compare the reproductive outcome of the tested intervention to that of a control group who will not receive the investigated cell treatment prior to embryo transfer.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria4

Participating in Assisted Reproduction Treatment
Having primary infertility
Having regular menstrual cycles
Scheduled to undergo embryo transfer of euploid embryos only

Exclusion Criteria8

Uterine pathologies
Endometrial bacterial infections
Active endometrial inflammation
Polycystic ovary syndrome
Presence of auto antibodies such as anti-TPO (thyroid peroxidase), anti-TG (thyroglobulin), ACA (anticentromere antibodies), APA (antiphospholipid antibodies), ANA (antinuclear antibodies), and anti-dsDNA
Presence of mutations involving the coagulation system such as deficiency of factor XII, Pro C, Pro S
Oncological condition
Positive HIV (human immunodeficiency virus), HCV (hepatitis C virus) or HBV (hepatitis B virus) tests

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Interventions

BIOLOGICALPBMC immunomodulated with IFNt

Autologous peripheral blood mononuclear cells (PBMC) isolated using a standard protocol will be cultured in the presence of interferon tau (IFNt) for 24 hours at 37 ˚C and administered in the uterine cavity of patients 1 day prior to embryo transfer.